NEW DELHI: The Subject Expert Committee (SEC) of the drug regulator today recommended granting an emergency use authorisation to Bharat Biotech’s Covaxin for children aged between 2-18.
An expert panel on Tuesday recommended Covaxin – Bharat Biotech’s COVID-19 vaccine for use on children between the ages of two and 18.
Final approval for the use of Covaxin on children will be given by the Drug Controller General of India.
Other conditions listed by the expert panel are: The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet; the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019; and the firm should submit risk management plan.
Bharat Biotech had last week submitted Phase 2/3 clinical trials data of children’s trials to the DCGI for its verification and subsequent approval for emergency use authorisation (EUA) for the jab.
Two doses of Covaxin are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.
This is the second COVID-19 vaccine to get approved for children in India. DGCI had, in August, approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout has not yet begun.
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